Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of cyclosporine 0.010% to treat atopic keratoconjunctivitis

Conditions: Atopic Conjunctivitis

Summary: this study evaluates the efficacy and safety of cyclosporine 0.010% eye drops in the treatment of atopic keratoconjunctivitis (chronic and severe inflammation of the eye). the study consists of a double-masked phase, and open-labeled phase, and an open-labeled maintenance phase. for the first 3 months of the study, patients will receive either masked cyclosporine 0.010% eye drops or vehicle four times daily; for the next 6 months, patients may receive open-labeled cyclosporine 0.010% eye drops four times daily. at month 9, patients who are in remission, will be re-randomized to receive either open-labeled cyclosporine 0.010% eye drops four times daily or twice daily.


Eligibility criteria:
inclusion criteria: * have a clinical diagnosis of atopic keratoconjunctivitis (chronic and severe inflammation of the eye) * be on stable doses of your current akc medications for at least 2 weeks exclusion criteria: * you have used contact lenses within 48 hours of day 1 or think you may have to wear contact lenses during the study * you are pregnant, breastfeeding, or planning to become pregnant during the study * you have used a calcineurin inhibitors (e.g. topical tacrolimus or topical pimecrolimus) on or around your eyes including eyelids within 4 weeks
seroprevalence of mers-cov igg in healthcare workers

Conditions: Coronavirus Infections

Summary: the investigators aim to do serosurvey of healthcare-personnel who had participated in treatment of confirmed patients of middle-east respiratory syndrome. the investigators collected the base-line (pre-exposure) serum of healthcare-personnel in a few centers, and will collect the post-exposure serum from about 25-30 centers in which confirmed mers patients had been treated. the investigators will deduct the seroprevalence of mers-cov igg among the healthy healthcare-personnel, and calculate the sero-conversion rate if possible. the investigators will subdivided the seroprevalence according to the degree of exposure and preparedness of personal protective equipment.

we aim to deduct the seroprevalence of healthcare-personnel (hcp) who had participated in treatment of confirmed patients of middle-east respiratory syndrome. in first step, we collected the base-line (pre-exposure) serum from the hcp who worked in the hospitals in which confirmed mers patients were treated. pre-exposure serum was collected in a few centers. if the serum was drawn within 3 weeks from initial exposure, then the serum was considered adequate as pre-exposure. (because, antibody against the mers-cov would be produced after more the 17-21 days of exposure). the serum was frozen. in second step, we will collect the post-exposure serum from the hcp who worked in the hospitals in which confirmed mers patients were treated or detected. we plan to include 25-30 centers. the timing of sample collection is 6-8 weeks after last contact with confirmed mers patients. the serum will also freeze. in third step, we will assay the presence of antibody in collected sample. we will use mers-cov elisa kit (euroimmune co.) as screening test and mers-cov ifa kit (euroimmune co.) as confirm test.

Eligibility criteria:
inclusion criteria: * healthcare-personnel who are working for hospitals in which confirmed mers patients were treated or detected * close contact with confirmed patient(s). * agree to informed consent exclusion criteria: * disagree to consent * confirmed mers patient

Keywords: mers healthcare personnel
radiopharmaceuticals analysis for detailed insights and international tracking of safety

Conditions: Cancer; Side Effect of Drug

Summary: little is known about cancer therapy-related radiopharmaceuticals drugs safety. here the investigators use vigibase (http://www.vigiaccess.org/), the world health organization (who) database of individual safety case reports, to identify and describe cases of cancer therapy-related radiopharmaceuticals drugs.

radiopharmaceuticals drugs especially for therapeutic purposes are responsible of a wide range of side effects. the investigators use vigibase, the world health organization (who) database of individual safety case reports, to identify cases of adverse drug reactions following treatment with radiopharmaceuticals drugs.

Eligibility criteria:
inclusion criteria: * cases reported in the world health organization (who) database of individual safety case reports (vigibase) exclusion criteria: * not related to radiopharmaceuticals

Keywords: pharmacovigilance adverse drug reactions nuclear medicine radiotherapeutics
efficacy of zoledronic acid in osteoporosis of children with multiple disabilities

Conditions: Multiple Disability; Osteoporosis

Summary: the main purpose of this study is the evaluation of the efficacy of zoledronic acid on bone density in children with osteoporosis caused by multiple disabilities. secondary purposes are: 1. description of child population with osteoporosis in the context of motor impairment in lorraine region 2. description of osteoporosis stage (level of bone mineralization and clinical consequences) in children with multiple disabilities 3. description of current osteoporosis preventive care 4. description of risk factors associated to bone status (drugs) 5. evaluation of zoledronic acid treatment on fracture numbers 6. evaluation of zoledronic acid on phosphocalcic profile 7. description of side effects of zoledronic acid in this indication 8. description of treatment effects in the sub-population of children with rett syndrome.


Eligibility criteria:
inclusion criteria: * non refusal of parents of participation of their child to the study * patients followed for multiple disabilities * osteoporosis: lumbar osteodensitometry z-score \<-2.5 sd associated or not to pathologic fracture exclusion criteria: * bone pathology due to other genetic reasons (rickets, osteogenesis imperfecta) * absence of multiple disabilities
clinical evaluation of 0.1% olopatadine hydrochloride ophthalmic solution in pediatric patients

Conditions: Allergic Conjunctivitis

Summary: the objective of this study is to further evaluate the safety of olopatadine ophthalmic solution 0.1% in japanese children with allergic conjunctivitis.


Eligibility criteria:
inclusion criteria: * patients whose parents or guardians can issue informed consent * patients aged over 7 and less than 16 at the baseline * patients confirmed to show type i allergy * patients with allergic conjunctivitis * patients having subjective symptoms at the baseline (itching sensation, foreign body sensation, eye pain, etc.) exclusion criteria: * patients having ocular itching sensation and injection caused by disease other than allergic conjunctivitis * patients having retinal detachment, diabetic retinopathy or progressive retinal disease * patients with a history of ocular infection, corneal herpes or relapsing corneal erosion of sudden onset or secondary to corneal injury * patients having received continuous treatment with corticosteroid within 3 months * patients having received immunotherapy * patients requiring continuous treatment of corticosteroid, immunosuppressors, non-steroidal anti-inflammatory agents, vasoconstrictors, anti-histamines, anti-allergy agents, herbal preparations indicated for "conjunctivitis" or any ophthalmic solution other than the test product * patients having undergone ocular laser therapy within 3 months * unilaterally blind patients (best corrected visual acuity: below 0.01) * patients with a history of allergy or hypersensitivity to olopatadine hydrochloride * patients necessitating the use of contact lens during the study period * other patients judged by the attending physician as inappropriate for study

Keywords: allergic conjunctivitis
causes of low digestive bleeding in proctology

Conditions: Lower Gastrointestinal Tract; Colorectal Surgery; Proctology

Summary: the various causes of bleeding proctological are well known to gastroenterologists in clinical practice but their proportions have not, to our knowledge, been dedicated epidemiological studies. investigators wanted to evaluate this data as part of a specialized consultation. investigators have prospectively collected the causes of gastrointestinal bleeding down the patients seen two of us in specialized proctology center. a clinical examination including an inspection, palpation and feel, and a anoscopy (when possible) were made during the consultation. local levies referred (s) histological and / or infection were also carried out if necessary. when she had not been made, a colonic exploration was offered to all patients over 45 years and / or when indicated by the pathological context. when there were several possible causes, the clinician holding one that seemed to be the main. patients consulting within four months postoperatively a proctology action were not included. the study period extended from september 2013 to july 2014 inclusive. the collection of anonymous data.

the various causes of bleeding proctological are well known to gastroenterologists in clinical practice but their proportions have not, to our knowledge, been dedicated epidemiological studies. investigators wanted to evaluate this data as part of a specialized consultation. investigators have prospectively collected the causes of gastrointestinal bleeding down the patients seen two of us in specialized proctology center. a clinical examination including an inspection, palpation and feel, and a anoscopy (when possible) were made during the consultation. local levies referred (s) histological and / or infection were also carried out if necessary. when she had not been made, a colonic exploration was offered to all patients over 45 years and / or when indicated by the pathological context. when there were several possible causes, the clinician holding one that seemed to be the main. patients consulting within four months postoperatively a proctology action were not included. the study period extended from september 2013 to july 2014 inclusive. the collection of anonymous data.

Eligibility criteria:
inclusion criteria: * all patients with proctological context exclusion criteria: * patients refusing to participate

Keywords: bleeding
stimulation of the rostral zona incerta for parkinson's disease

Conditions: Parkinson Disease

Summary: patients with parkinson's disease who undergo deep brain stimulation surgery receive symptom relief due to electrical stimulation of the brain. the target for the stimulation, in many cases, is the subthalamic nucleus (stn). the brain area just above the stn is called the rostral zona incerta (rzi). the rzi may be a potential target for deep brain stimulation, in combination with the stn.

deep brain stimulation (dbs) of an area of the brain called the subthalamic nucleus (stn) is an effective treatment in parkinson's disease (pd). however, stimulating the stn can lead to unwanted side effects that involve muscle movements (dyskinesias) and behavior and mood problems. dbs of a different brain structure, called the rostral zona incerta (rzi), has been demonstrated to be as effective as stimulating the stn, without any unwanted side effects in several studies. however, there is great variability in reported efficacy and adverse effects of rzi stimulation likely due to challenges in locating this area in the brain. the goals of this study are 1) to develop an improved method for targeting the rzi 2) determine efficacy of rzi with stn stimulation compared with stn stimulation alone, 3) evaluate any stimulation adverse effects of combined stimulation of the rzi and stn.

Eligibility criteria:
inclusion criteria: * parkinson's disease, * no current deep brain stimulating electrodes exclusion criteria: * other movement disorders, * parkinson's disease with already implanted electrode.

Keywords: deep brain stimulation
microvascular and metabolic effects of high-intensity interval exercise training

Conditions: Obesity; Overweight; Physical Activity

Summary: the study investigates the effects of high intensity interval training (hiit) versus continuous training (ct), combined or not with fasting, on capillary density, microvascular function, cardiometabolic risk markers, functional capacity, and quality of life, in overweight or obese sedentary women with cardiometabolic risk factors. the use of hiit could promote greater improvements in these parameters than ct. furthermore, the positive effects of exercise may increase when it is performed in the fasting state, compared to exercise performed in the fed state.

physical inactivity and increased caloric intake play important roles in the pathophysiology of obesity. increases of physical activity and modifications of eating behaviors are first-line interventions which, however, are not easily implemented, and lack of time to exercise and difficulties in coping with different diets are common reasons for failure. high-intensity interval training (hiit) is a "faster" alternative to moderate-intensity continuous training (ct). conversely, intermittent fasting is also an alternative to more complex diets, as it restricts caloric intake to a specified period of time without major diet composition changes. the combination of hiit and fasting may therefore provide incremental benefits. sedentary women aged ≥ 30 years and ≤50 years, with body mass index ≥25 kg/m2 and cardiometabolic risk factors, will be randomized to hiit performed in the fasting state, hiit performed in the fed state, ct in the fasting state or ct in the fed state. cardiometabolic parameters, anthropometric indices, cardiorespiratory fitness, quality of life and microvascular function (cutaneous capillary density and microvascular reactivity evaluated by laser speckle contrast imaging) will be evaluated before the initiation of the interventions and 4 weeks thereafter.

Eligibility criteria:
inclusion criteria: * female gender * age≥ 30 years and ≤50 years * premenopausal status * body mass index \>25 kg/m2 * at least one of the following: waist circumference ≥80 cm (women); triglycerides ≥150 mg/dl or treatment for this lipid abnormality; high density-lipoprotein cholesterol \<50 mg/dl (women), or treatment for this abnormality; fasting plasma glucose ≥100 mg/dl exclusion criteria: * any cardiovascular disease, including systemic hypertension * diabetes mellitus * chronic pulmonary disease * any systemic disease or condition that might reduce the adherence or tolerance to exercise or fasting * orthopedic or neurologic conditions that might impair exercise training * pregnancy or breastfeeding * abnormalities elicited at exercise treadmill testing that preclude the initiation of exercise training * current engagement in any exercise training protocol

Keywords: obesity microcirculation endothelial function laser speckle imaging capillary density
assessing adherence to home telemedicine in individuals with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this is a single-site feasibility pilot study to determine if patients with copd with an increased risk of exacerbation will use an in-home copd telemonitoring system for three months that collects lung measures, pulse oximetry, and medication compliance.

this is a single-site, prospective, open label trial evaluating home telemonitoring for patients with copd and a history of increased exacerbation risk. the purpose of this study is to determine whether automated home monitoring of medication compliance and biometric parameters \[forced expiratory capacity in one second (fev1), forced vital capacity (fvc), peak inspiratory flow rate (pifr), inspiratory capacity (ic), pulse oximetry, and symptoms\] is acceptable to patients, can improve adherence, and may improve clinical outcomes and reduce exacerbations and avoidable 30-day readmissions. slow spirometry will be performed sundays, mondays, wednesdays, fridays and saturdays. forced spirometry will be performed tuesdays and thursdays.

Eligibility criteria:
inclusion criteria: * male or female patients * 40 to 80 years of age * english speaking * spirometry confirmed copd (post-bronchodilator fev1/fvc\<0.70) and post-bronchodilator fev1% predicted \<80% at screening visit. (target 50% of recruitment with post-bronchodilator fev1\<50% predicted (severe obstruction)) * increased copd exacerbation risk defined as either of the following in the prior 12 months: * one hospitalization for copd exacerbation * two outpatient copd exacerbations requiring treatment with steroids and/or antibiotics * signed informed consent exclusion criteria: * unable to perform spirometry on their own following training. * planned discharge to a nursing home or other extended care facility * co-morbid conditions likely to result in non-preventable readmissions (e.g., terminal malignancy, cirrhosis or end-stage liver disease, chronic wound infections, etc.) * uncontrolled or untreated medical conditions that would predispose the patient to recurrent copd exacerbations (i.e., bronchiectasis) * patient refusal to or inability to comply with monitoring requirements, for any reason including but not limited to dementia, a history of dementia, or other significant mental impairment * patients enrolled in any other clinical trials or therapeutic studies of drugs, devices, or biologics

Keywords: home telemedicine home spirometer
ctdna based mrd testing for nac monitoring in tnbc

Conditions: TNBC - Triple-Negative Breast Cancer; Minimal Residual Disease

Summary: a prospective, multicenter, observational study to evaluate the correlation of molecular residual disease (mrd) detection using circulating tumor dna guided test to pathological complete response (pcr) after neoadjuvant chemotherapy (nac) in stage i-iii triple negative breast cancer (tnbc). results from this study aim to improve mrd detection and disease outcomes for future patients.

next personal cta (clinical trial assay) is a patient-specific, tumor-informed device which allows for detection of mrd from cfdna. by using next generation sequencing technology, whole genome sequencing (wgs) is conducted from dna derived from patient tumor and normal samples. a tumor informed personalized panel is then constructed that uses only a selection of dna targets from the wgs by applying bioinformatic filters. the targeted personalized panel is then sequenced using ngs and dna derived from cfdna from plasma samples. the data from the cfdna ngs are then further analyzed using bioinformatics filters to report the mrd status.

Eligibility criteria:
inclusion criteria: 1. have histologically documented tnbc (defined as er expression ≤10% by ihc, pr expression≤10% by ihc and her2 0 or 1+ by ihc or fish ratio \<2 or her2 gene copy number of \<6). 2. early-stage breast cancer (stage i-iii) and scheduled to undergo nac treatment with curative intent. 3. be informed of the investigational nature of the study and all pertinent aspects of the trial. 4. have the ability to understand and the willingness to sign a written informed consent document in accordance with institutional and federal guidelines. 5. be ≥ 18years of age. 6. patient who are scheduled to start nac. 7. be willing to provide blood samples before and during treatment. 8. have available biopsy tissue. exclusion criteria: 1. receiving concurrent anti-neoplastic therapy for another malignancy. 2. stage iv disease. 3. current or history of another primary cancer within 5 years of study entry, with the exception of basal or squamous cell skin cancer, or non-invasive malignancy. 4. history of allogeneic bone marrow or organ transplant. 5. blood transfusion within two weeks before collection of blood for central ctdna testing. 6. started systemic therapy for their breast cancer. 7. pregnancy

Keywords: ctdna liquid biopsy breast cancer mrd nac tnbc next personal®
reamer irrigator aspirator (ria) vs autogenous iliac crest bone graft (aicbg) for the treatment of non-unions

Conditions: Nonunion of Bone Graft; Fractures Non Union

Summary: the specific question the investigators will seek to answer is: can the reamer irrigator aspirator (ria) provide a bone graft source for the treatment of nonunions that is equally effective to autogenous iliac crest bone graft (aicbg) while resulting in a decreased amount of post-operative pain and a lower rate of complications?

all subjects will be pre-screened by the treating physician. subjects who present with a nonunion of a long bone will be invited to speak to the research coordinator regarding the study. an internet based randomization system will be used to allocate subjects to treatment groups. participating sites will be given a unique id and password to log into the secure website and register their subject. treating physicians will use 1 of 2 bone graft harvesting methods in patients with a nonunion of a long bone requiring grafting. the first method involves harvesting bone graft from the iliac crest area. the second method involves using the ria to harvest bone graft from the femoral canal. clinical assessments will occur at the time of hospital admission (baseline), at post-op day 1, and then at 2 weeks, 6 weeks, 3 months, 6 month, 12 months and 24 months post-surgery. surgical procedure at the nonunion site will not be standardized as this will vary greatly. surgeons may use bone graft substitutes at the recipient site at their discretion. we will however, standardize surgical techniques for harvesting of the graft from the donor site.

Eligibility criteria:
inclusion criteria: * subjects male or female, aged 18-65 * subjects with a nonunion of a long bone requiring bone grafting in the -opinion of their orthopaedic surgeon (nonunion will be defined as "9 months duration of the nonunited fracture with no evidence of progressive healing over the previous 3 months") * subjects must have an uninjured, healthy iliac crest and a femur that has not previously been operated on * subjects must provide informed consent exclusion criteria: * subjects requiring a structural bone graft * subjects presenting with an active systemic or local infection * subjects with a nonunion due to pathologic fracture * patients with severely compromised soft-tissue coverage at the nonunion site, sufficient to impair bone healing * patients receiving radiation, chemotherapy, immunosuppression, or chronic steroids * subjects with whom there are likely to be problems, in the judgment of the investigator or research coordinator, with maintaining follow-up (such as no fixed address, plans to move out of town in the next year, etc.).

Keywords: non union bone defect tibia non union femur non union bone graft